Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction

NCT07538336 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25-45438
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study is testing a medication called emapalumab to see if it can help people who have had a lung transplant and are experiencing a sudden drop in lung function, called acute lung allograft dysfunction (ALAD). ALAD is a serious condition that can happen after a lung transplant and can lead to worsening breathing and other complications. Right now, there is no approved treatment for ALAD. The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days.

Conditions

Lung Transplant

Keywords

ALAD; Acute Lung Allograft Dysfunction; Lung Transplant

Outcome Measures

Primary Outcomes (1)

• Recovery from Acute Lung Allograft Dysfunction, defined by International Society for Heart and Lung Transplantation guidelines as a return to within 10% of baseline FEV1 within 90 days

  90 days

Secondary Outcomes (1)

• CXCL9 area under the curve (AUC), safety outcomes and retransplant-free survival will be used to measure ALAD Progression

  90 days

Study Arms (2)

Part I (finding the right dose)

ACTIVE COMPARATOR

Small groups of participants will receive different doses of emapalumab through an IV (into a vein). The goal is to find the dose that best blocks harmful inflammation in the lungs.

Drug: Emapalumab

Part 2 (testing how well it works)

OTHER

Participants will receive the selected dose of emapalumab or placebo. Doctors will: Monitor blood and lung markers Check for viruses Follow your progress weekly for about 4 weeks

Drug: Emapalumab; Drug: Placebo

Interventions

Emapalumab DRUG

This is a one-time infusion

Part 2 (testing how well it works); Part I (finding the right dose)

Placebo DRUG

This is a one-time infusion of inactive drug

Part 2 (testing how well it works)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipients ≥10 months post-lung transplant who are enrolled in existing biorepository study (IRB #13-10738) will be approached if they have ALAD and elevated AI2 and CXCL9 levels
• Age: ≥18 years old
• Informed Consent: Ability to provide written informed consent to participate in the study.

You may not qualify if:

• Active CMV or EBV Infection: Active reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) based on plasma PCR testing.
• Severe Comorbidities: Presence of severe conditions likely to compromise study participation or outcomes (e.g., terminal illness).
• Pregnancy or Breastfeeding: Women who are pregnant or breastfeeding at the time of screening.
• Concurrent Immunosuppressive Therapy Trials: Use of investigational agents or therapies other than standard of care post-transplant immunosuppression.
• Allergy to Study Drug: Known hypersensitivity to emapalumab or any of its components.
• Insufficient Baseline Data: Lack of prior baseline FEV1 data for comparison.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (13)

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Related Links

• The induction of class I and II major histocompatibility complex by allogeneic stimulation is dependent on the transcription factor interferon regulatory factor 1 (IRF-1): observations in IRF-1 knockout mice
• Efficacy and Safety of the Janus Kinase 1 Inhibitor Itacitinib (ITA) in Patients with Bronchiolitis Obliterans (BOS) Syndrome Following Double Lung Transplant. The Journal of Heart and Lung Transplantation

MeSH Terms

Interventions

Emapalumab

Study Officials

• John Greenland, Dr.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• John Belperio, Dr.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Legna Betancourt

CONTACT

(415) 476-8073; legna.betancourt@ucsf.edu

Principal Investigator

CONTACT

john.greenland@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multi-center, prospective, biomarker-driven, placebo-controlled, randomized interventional study.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)